Title
Category
Credits
Event date
Cost
Site Perspective: Examine the Process for Maintaining Quality and Ensuring Results
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take you through how to develop and implement a quality management plan to ensure you get good clinical trial results on your investigator-initiated trial (IIT).
The "Tiny" Details that Can Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take to you about the 3 major reasons that protocols requirement amendments and how to avoid them.
5 Tips for Developing and Maintaining an IND
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through a quick 5 tips that will help you and your team successfully manage an IND.
Activation 101- Who are the Players
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all the different players and roles involved in clinical trial activation.
Activation 201- What is the Role of the Activation PM
  • 1.00 Participation
$0.00
Course DescriptionThis talk given by Kaitlin Morrison, PhD takes you through the role of the activation project manager and how they facilitate activation of treatment clinical trials. 
Creating your Clinical Trial Protocol
  • Investigator Initiated Trials
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Leila Kiefer, PhD gives a survey of clinical protocol goals and best practices from literature, guidances, and experiential knowledge.
Everything a PI Needs to Know about LCCC as an IND Sponsor
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through the sponsor responsibilities outlined by Good Clinical Practices (GCP) and FDA regulations and what LCCC infrastructure and processes are used to meet those obligations.
Everything that a PI Needs to Know about Holding an IND
  • Investigator Initiated Trials
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all of the major responsibilities of holding an LCCC sponsored IND. She takes you through errors made in the past, so you can make sure that you don’t make them on your study.
Gene Therapy- FDA and Local Considerations
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process. This includes insights into specific protocol requirements and additional review bodies that will oversee your study.
Hot and Cold Topics for Investigators
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through the top topics investigators are asking about and the other questions that they should be asking too.These topics include:

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